Overview on Biopharmaceutics Classification System (BCS) based biowaiver requirements in African countries

  • Nidhi Sagar Husband
  • Iva Dhulia
  • Himani Patel
  • Umesh Dobariya
  • Sandip Sarvaiya

Abstract

Biopharmaceutics Classification System (BCS)-based biowaiver are meant to reduce the need for establishing in vivo bioequivalence in situations where in vitro data may be considered to provide a reasonable estimate of the relative in vivo performance of two products.


The BCS is a scientific approach designed to predict medicinal absorption based on the aqueous solubility and intestinal absorptive characteristics of the Pharmaceutical product. To ensure interchangeability, the multisource product must be therapeutically equivalent to the comparator product. Types of in vivo equivalence studies include comparative pharmacokinetic studies, comparative pharmacodynamic studies and comparative clinical studies.


This article briefly explains the BCS based biowaiver requirements in six major African countries i.e. Zimbabwe, South Africa, Uganda, Kenya, Botswana and Tanzania which facilitates regulatory medicine approval process when the dossier (application) is approved based on evidence of equivalence other than In vivo studies.

Keywords: BCS (Biopharmaceutics Classification System), MCAZ (Medicines Control Authority of Zimbabwe), MCC (Medicines Control Council), NDA (National Drug Authority), WHO (World Health Organization)

Downloads

Download data is not yet available.

References

1. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. In: WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms Annex 12 World Health Organization [Internet]. Geneva: WHO; 2006 [cited 2021 Apr 03]. Available from: https://www.who.int
2. Guidelines on Submission of Documentation for Marketing Authorisation of a Pharmaceutical Product for Human Use [Internet]. Uganda: NDA [cited 2021 Mar 15]. Available from: https://www.nda.or.ug
3. Annex to Guidelines on Submission of Documentation for Registration of a multisource (Generic) Finished Pharmaceuticals Products [Internet]. Zimbabwe: MCAZ; 2009 Aug [cited 2021 Apr 12]. Available from: https://www.mcaz.co.zw
4. Shah VP, Rădulescu FS, Miron DS, Yacobi A. Commonality between BCS and TCS. International Journal of Pharmaceutics. [Internet]. 2016 Jul 25 [cited 2021 Apr 11]; 509 (1-2):35-40. Available from: https://www.sciencedirect.com/science/journal/03785173
5. Guideline for Bioavailability and Bioequivalence [Internet]. Botswana: MOH; 2015 Apr [cited 2021 Mar 31]. Available from: http://www.moh.gov.bw/
6. Guidelines on Therapeutic Equivalence Requirements [Internet]. Tanzania: TFDA; 2015 Jan [cited 2021 Mar 31]. Available from: http://www.tfda.or.tz/
7. Medicines Control Council, Biostudies [Internet]. South Africa: MCAZ; 2015 Jul [cited 2021 Mar 31]. Available from: http://www.mccza.com/
8. Guidelines-for-registration-of-Human-and-Veterinary-Medicines [Internet]. Kenya: Pharmacy Board Kenya; 2010 [cited 2021 Mar 15]. Available from: http://www.pharmacyboardkenya.org/
9. Sarkar A. Types of Biowaivers: A Discussion. Int J Drug Reg Affairs [Internet]. 2019 Sep 15 [cited 2021 Jun 15];7(3):14-0. Available from: http://ijdra.com/index.php/journal/article/view/329
Statistics
131 Views | 20 Downloads
How to Cite
Sagar, N., I. Dhulia, H. Patel, U. Dobariya, and S. Sarvaiya. “ Overview on Biopharmaceutics Classification System (BCS) Based Biowaiver Requirements in African Countries”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 2, June 2021, pp. 26-29, doi:10.22270/ijdra.v9i2.465.